GUEST CONTRIBUTORS

  • Unpacking The Latest Brexit Developments And Their Potential Impact On Pharma
    Unpacking The Latest Brexit Developments And Their Potential Impact On Pharma

    With less than a year to go until the March 31, 2019 divorce date for the U.K. and the EU, one would be forgiven for thinking there would already be a plan in place to deal with an event that will have such a profound global impact on the pharmaceutical industry. However, manufacturers still seemingly have to prepare for any possibly scenario, while continuing to wait for clarity.

  • Determining Significant Vs. Nonsignificant Risk In Medical Devices
    Determining Significant Vs. Nonsignificant Risk In Medical Devices

    Knowing how to classify your device as either SR or NSR is not a clearly defined task. There are implications for each decision made as you proceed through development, and the burden is on you to understand and to provide what the FDA will require.

  • Best Practices In Environmental Monitoring Sampling — Transportation & Analysis
    Best Practices In Environmental Monitoring Sampling — Transportation & Analysis

    The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification can be broken into six phases to increase the likelihood of success during inspection for licensure of a facility. This article discusses the final two phases.

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PHARMA OUTSOURCING WHITE PAPERS

Choosing The Best Sterile Dosage Form For Your Phase I  Clinical Supply Needs Choosing The Best Sterile Dosage Form For Your Phase I Clinical Supply Needs

When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.

In-House Versus Outsource: A Decision-Making Guide In-House Versus Outsource: A Decision-Making Guide

Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.

9 Reasons To Consider A Single-Use Fermentor

Dedicated Fermentation Technology Replacing Stainless Steel Systems in Bioprocess Markets

Scalable Strategies For Parenteral Dosage Form Selection

Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.

 

Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing

A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

Accelerate Flavivirus Vaccine Production With Modern Bioprocess Tools And Solutions

This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Ready-To-Use Fluid Management Solutions For Chromatography Systems

A selection of fluid management components from GE Healthcare’s ReadyToProcess platform of disposable and single-use equipment was used to arrange buffer and sample management solutions for four typical large-scale chromatography setups.

An Examination Of Nunc™ Cell Factory™ System For Consistent Reliable Production Of Large Quantities Of Cells

Thermo Scientific™ Nunc™ Cell Factory™ systems are solutions designed for adherent cell culture. These systems consist of multiple polystyrene growth surfaces, assembled together to maximize the surface area available for cell growth while minimizing the incubator volume required for maintaining cells. Nunc Cell Factory systems are popular in fields where large quantities of cells are required and are a reliable tool for the production of vaccines, recombinant proteins, and for the generation of cell mass.

Scalability Of Microcarrier Bead Separation Using The Harvestainer System

Current techniques used to separate adherent mammalian cells from microcarrier beads often use sophisticated equipment, requiring significant capital expenditure as well as routine maintenance, and cleaning and sterilization between uses.

Engineering Characterization Of The Single-Use Xcellerex XDR-2000 Stirred-Tank Bioreactor System

This application note describes the physical characteristics of the XDR-2000 bioreactor system suitable for use in mammalian cell culture applications. 

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error May 29 - 29, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner May 30 - 30, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Pediatric Clinical Trials: Special Considerations and Requirements June 4 - 4, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
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